Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies
NCT04504708 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2022-10-21
Summary
ZX-101A-101 is a Phase 1/2a, first-in-human, open-label, multicenter, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary antitumor activity of ZX-101A administered orally (PO) once daily (QD) in 28-day cycles in patients with relapsed/resistant or refractory advanced hematologic malignancies \[Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), indolent NHL, and other NHL subtypes).
Conditions
Interventions
- DRUG
-
ZX-101A
Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
Sponsors & Collaborators
-
Hangzhou Zenshine Pharmaceuticals Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Xiaolin Qin, PhD · Zenshine Pharmaceutical, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-17
- Primary Completion
- 2022-07-08
- Completion
- 2022-07-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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